Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a chemical indicator that reacts to steam sterilization parameters, with a visual readout. There is no mention of computational processing, algorithms, or learning from data.

Therapeutic

No
The device is an integrating indicator used to monitor steam sterilization cycles, not to treat a medical condition or disease.

Diagnostic

No

This device is a chemical indicator used to monitor steam sterilization cycles in healthcare settings, ensuring that sterilization criteria have been met. It indicates whether items are sterile, but it does not diagnose a medical condition in a patient.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "single use device" that is "included in a pack or load in a steam sterilizer" and has a "dark bar on the device" that enters an "ACCEPT (OK) window". This describes a physical, chemical indicator, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The described device is a chemical indicator used to monitor the effectiveness of steam sterilization cycles for medical instruments and supplies. It reacts to the physical parameters of the sterilization process (temperature, time, steam) to indicate whether the cycle was successful in achieving sterilization conditions.
Intended Use: The intended use is to monitor the sterilization process of medical devices, not to diagnose or provide information about a patient's health.
Device Description: The description clearly states it's a "single use device used by healthcare providers to monitor steam sterilization cycles."
Lack of Biological Samples: The device does not interact with or analyze any biological samples from a patient.

Therefore, this device falls under the category of a medical device used in the sterilization process, but it is not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Steam Sterilization Cycles:

· 250°F/121°C, 30 minutes Gravity
· 270°F/132°C, 4 minutes Dynamic Air Removal
· 270°F/132°C, 15 minutes Gravity
· 275°F/135°C, 3 minutes Dynamic Air Removal
· 275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles (IUSS):

· 270°F/132°C, 4 minutes Dynamic Air Removal
· 270°F/132°C, 3 minutes Gravity
· 270°F/132°C, 10 minutes Gravity
· 275°F/135°C, 3 minutes Dynamic Air Removal
· 275°F/135°C, 3 minutes Gravity
· 275°F/135°C, 10 minutes Gravity

Product codes (comma separated list FDA assigned to the subject device)

JOJ

Device Description

The VERIFY® STEAM Integrating Indicator is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY® STEAM Integrating Indicator is included in a pack or load in a steam sterilizer and the load is processed in accordance with the sterilizer manufacturer's directions. Prior to the use of the processed items, the Integrator is observed. If the dark bar on the device enters the ACCEPT (OK) window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare providers

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing was conducted to verify that the proposed VERIFY® STEAM Integrating Indicator meets the requirements for integrating indicators in accordance with the Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators for integrating indicators as well as ANSI/AAMI/ISO 11140-1:2014.

Study Type: BIER Vessel Testing
Sample Size: 3 Lots
Key Results: Pass result at SV for each temperature claimed (23.0 min at 121°C, 2.0 min at 132 °C, 1.2 min at 135 °C). Fail result at 15% below SV for each temperature claimed. Fail result at 1°C below SV for each temperature claimed. (Result: PASS)

Study Type: Simulated Use Testing in Claimed Sterilization Cycles
Key Results: 100% Pass result under pass conditions. 100% Fail result under fail conditions. (Result: PASS)

Study Type: Dry Heat Testing
Key Results: Fail result when exposed to 140°C dry heat for 30 min. (Result: PASS)

Study Type: Verification of integrator stated values at biological indicator growth-negative cycle conditions
Key Results: Integrator does not reach endpoint before the biological indicator is inactivated. (Result: PASS)

Study Type: Offset/Bleeding
Key Results: Integrator shall not bleed or offset. (Result: PASS)

Conclusion: The results of the VERIFY® STEAM Integrating Indicator performance testing demonstrate that both perform as intended in the claimed steam sterilization cycles and the proposed device is substantially equivalent to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K012195

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of a human figure, composed of three overlapping profiles, symbolizing health and well-being.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 12, 2016

Steris Corporation Bill Brodbeck, Ph.D. Director, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060

Re: K152630

Trade/Device Name: VERIFY® STEAM Integrating Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization process indicator Regulatory Class: Class II Product Code: JOJ Dated: April 11, 2016 Received: April 12, 2016

Dear Dr. Brodbeck:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K152630

Device Name VERIFY® STEAM Integrating Indicator

Indications for Use (Describe)

The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Steam Sterilization Cycles:

· 250°F/121°C, 30 minutes Gravity
· 270°F/132°C, 4 minutes Dynamic Air Removal
· 270°F/132°C, 15 minutes Gravity
· 275°F/135°C, 3 minutes Dynamic Air Removal
· 275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles (IUSS):

· 270°F/132°C, 4 minutes Dynamic Air Removal
· 270°F/132°C, 3 minutes Gravity
· 270°F/132°C, 10 minutes Gravity
· 275°F/135°C, 3 minutes Dynamic Air Removal
· 275°F/135°C, 3 minutes Gravity
· 275°F/135°C, 10 minutes Gravity

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/4/Picture/1 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a bold, sans-serif font, with a registered trademark symbol to the right. Below the word is an image of several horizontal, wavy lines in a light blue color, resembling water waves.

510(k) Summary for VERIFY® STEAM Integrating Indicator

Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (216) 354-2600 Fax No: (216) 639-4459

Manufacturing Facility

Dana Products, Inc. 11457 Melrose Street Franklin Park, IL 60131

Contact:

Bill Brodbeck, Ph.D. Director, Regulatory Affairs Telephone: (440) 392-7690 (440) 357-9198 Fax No: e-mail: William brodbeck(@steris.com

May 12, 2016 Submission Date:

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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1. Device Name

Trade Name:	VERIFY® STEAM Integrating Indicator
Device Classification:	Class II
Common/usual Name:	Indicator, physical/chemical sterilization process
Classification Name:	Indicator, physical/chemical sterilization process
(21 CFR 880.2800, JOJ)

2. Predicate Device

Dana Steam Sterilization Integrator (K012195), Dana Products Inc.

3. Description of Device

The VERIFY® STEAM Integrating Indicator is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY® STEAM Integrating Indicator is included in a pack or load in a steam sterilizer and the load is processed in accordance with the sterilizer manufacturer's directions. Prior to the use of the processed items, the Integrator is observed. If the dark bar on the device enters the ACCEPT (OK) window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.

4. Intended Use

The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Steam Sterilization Cycles:

· 250°F/121°C, 30 minutes Gravity
· 270°F/132°C, 4 minutes Dynamic Air Removal
· 270°F/132°C, 15 minutes Gravity
· 275°F/135°C, 3 minutes dynamic air removal
· 275°F/135°C, 10 minutes Gravity

6

Steam Sterilization Cvcles (IUSS):

· 270°F/132°C, 4 minutes Dynamic Air Removal
· 270°F/132°C, 3 minutes Gravity
· 270°F/132°C, 10 minutes Gravity
· 275°F/135°C, 3 minutes dynamic air removal
· 275°F/135°C, 3 minutes Gravity
· 275°F/135°C, 10 minutes Gravity

ડ. Description of Safety and Substantial Equivalence

The proposed and predicate devices are single use integrating indicators for use in monitoring steam sterilization cycles. The products are identical in design with the exception of the labeling, which is being revised as a result of rebranding the device under the VERIFY product family (STERIS purchased Dana Products Inc. in March, 2015). The differences between the proposed VERIFY® |STEAM Integrating Indicator and the predicate Dana Steam Sterilization Integrator are limited to expanding the indications for use statement to include use of the device to monitor various steam sterilization cycles. These differences do not raise any new issues of safety and efficacy. Performance testing has been conducted for monitoring all claimed steam sterilization cycles in accordance with the Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators.

6. Technological Characteristics

The proposed and predicate devices are single use integrating indicators for use in monitoring particular steam sterilization cycles. The device components, mechanism of action, and endpoint are the same as the predicate's and when exposed to the defined processing conditions, the proposed and predicate devices exhibit a visible migration of the included chemistry to indicate that stated values have been achieved.

Table 5-1 contains a comparison of technological characteristics and specifications of the proposed VERIFY® STEAM Integrating Indicator to the predicate Dana Steam Sterilization Integrator.

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	Proposed	K012195	Comparison
Feature	VERIFY® STEAM
Integrating Indicator	Dana Steam Sterilization
Integrator
Intended use	The integrating indicator is
designed to chemically react
over time with the critical
parameters of steam
sterilization cycle within a
specified tolerance. The
integrating indicator strip is
intended to be placed in each
pack, pouch, container, tray or
other containment device to
function as an independent
monitor of critical parameters
for the following sterilization
cycles:
Steam Sterilization Cycles:
•250°F/121°C, 30 minutes
Gravity
•270°F/132°C, 4 minutes
Dynamic Air Removal
•270°F/132°C, 15 minutes
Gravity
•275°F/135°C, 3 minutes
dynamic air removal
•275°F/135°C, 10 minutes
Gravity
Steam Sterilization Cycles
(IUSS):
•270°F/132°C, 4 minutes
Dynamic Air Removal
•270°F/132°C, 3 minutes
Gravity
•270°F/132°C, 10 minutes
Gravity
•275°F/135°C, 3 minutes
dynamic air removal
•275°F/135°C, 3 minutes
Gravity
•275°F/135°C, 10 minutes
Gravity	Dana Steam Sterilization
Integrators are intended to be
used to monitor critical
parameters in steam
sterilization cycles in
healthcare facilities. The
critical parameters for which
the integrators will respond
are time and temperature
(when steam is present). The
end point is determined by the
migration of the steam
sensitive dye to an area
marked safe on the indicator.
The integrators are intended to
be used in 30 minute gravity
cycles at 250 degrees F and 3
minute gravity and pre-
vacuum cycles at 270 degrees
F.	The intended use
statement has been
updated to reflect
specific uses of the
subject device as
well expand the
indicated cycles to
include those
commonly utilized
in healthcare
facilities. Testing in
conformance with
the Guidance for
Industry and FDA
Staff: Premarket
Notification
[510(k)]
Submissions for
Chemical Indicators
for integrating
indicators addresses
any concerns
regarding the safety
and efficacy of the
proposed device in
regards to the
claimed steam
sterilization cycles.

Table 5-1. Device Comparison Table

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K152630 Response to 5/12/16 Interactive Review

VERIFY® STEAM Integrating Indicator

	Proposed	K012195	Comparison
Feature	VERIFY® STEAM	Dana Steam Sterilization
	Integrating Indicator	Integrator
Device
design -
components	Backing material with
embossed cavity containing
temperature sensitive chemical
and coloring dye, wicking strip,
covered with laminated paper
containing labeling and
windows.	Backing material with
embossed cavity containing
temperature sensitive chemical
and coloring dye, wicking strip,
covered with laminated paper
containing labeling and
windows.	Device design and
components are
identical with
exception of the
printed labeling.
Indicator
agent	Proprietary formulation	Proprietary formulation	The indicator agent
is identical to the
predicate.
Sterilization
method and
cycles	Per intended use above.	30 minute gravity cycles at
250 degrees F and 3 minute
gravity and pre-vacuum cycles
at 270 degrees F.	The intended cycles
vary between
indicators. Intended
cycles for the
proposed device will
be verified and
validated in
accordance with the
Guidance for
Industry and FDA
Staff: Premarket
Notification
[510(k)]
Submissions for
Chemical Indicators.
Mechanism
of action	Proprietary	Proprietary	Mechanism of
action is identical to
predicate.
Endpoint
specifications	The end point is determined
by the migration of the steam
sensitive dye to an area
marked ACCEPT (OK) on the
indicator. Endpoint is reached
at the stated value (SV) for
each claimed temperature.
Endpoint is not reached at the
stated value - 15% time and/or
-1°C.	The end point is determined
by the migration of the steam
sensitive dye to an area
marked safe on the indicator.
Endpoint is reached at the
stated value (SV) for each
claimed temperature. Endpoint
is not reached at the stated
value - 15% time and/or -1°C.	The end point is the
same for proposed
and predicate
devices.
Feature	Proposed
VERIFY® STEAM
Integrating Indicator	K012195
Dana Steam Sterilization
Integrator	Comparison
Comparison
of integrator
stated values
at biological
indicator
growth-
negative
cycle
conditions	Integrator does not reach
endpoint before the biological
indicator is inactivated.	Integrator does not reach
endpoint before the biological
indicator is inactivated	Same performance
observed.
Shelf-life	5 years	5 years	Proposed and
predicate devices
have the identical
design and therefore
carry the same shelf-
life claims.
Standard /
Guidance	Conforms to the Guidance for
Industry and FDA Staff:
Premarket Notification
[510(k)] Submissions for
Chemical Indicators for
integrating indicators and
ANSI/AAMI/ISO 11140-
1:2014: Sterilization of Health
Care Products - Chemical
Indicators - Part 1: General
Requirements.	Conforms to ST60:
Sterilization of Health Care
Products - Chemical Indicators

Part 1: General
Requirements. | Both proposed and
predicate devices
meet the applicable
standards at the time
of their introduction
into interstate
commerce. |

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K152630 Response to 5/12/16 Interactive Review VERIFY® STEAM Integrating Indicator

7. Performance Testing

Performance testing was conducted to verify that the proposed VERIFY® STEAM Integrating Indicator meets the requirements for integrating indicators in accordance with the Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators for integrating indicators as well as ANSI/AAMI/ISO 11140-1:2014.

Table 5-2 summarizes the verification activities that were performed, with their respective acceptance criteria and results, to demonstrate that the proposed VERIFY® STEAM Integrating Indicator is as safe and is as effective. These studies confirm that the proposed device's performance meets the requirements of its predefined acceptance criteria and intended uses, and qualify the proposed device for use in the claimed steam sterilization cycles.

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Stated Values

The subject device (integrator indicator) testing was performed in a bier vessel using the following stated values shown below at the following temperatures (see Table 5-2). The integrator indicator showed a passing result when the chemicals in the subject device reacted to all critical parameters in the bier vessel.

Test of 3 Lots	Acceptance Criteria	Study Result
BIER Vessel Testing	Pass result at SV for each temperature claimed
Stated values are:
• 23.0 min at 121°C
• 2.0 min at 132 °C
• 1.2 min at 135 °C
Fail result at 15% below SV for each
temperature claimed
Fail result at 1°C below SV for each
temperature claimed	PASS
Simulated Use Testing in
Claimed Sterilization
Cycles	100% Pass result under pass conditions
100% Fail result under fail conditions	PASS
Dry Heat Testing	Fail result when exposed to 140°C dry heat
for 30 min	PASS
Verification of integrator
stated values at biological
indicator growth-negative
cycle conditions	Integrator does not reach endpoint before the
biological indicator is inactivated	PASS
Offset/ Bleeding	Integrator shall not bleed or offset	PASS

Table 5-2. Verification Results Summary

The results of the VERIFY® STEAM Integrating Indicator performance testing demonstrate that both perform as intended in the claimed steam sterilization cycles and the proposed device is substantially equivalent to the predicate device.

8. Conclusion

The proposed device design is identical to that of predicate device, with the exception of the relabeling under the VERIFY brand. The intended use of the proposed device adds additional cycles and clarification of use conditions. The VERIFY® STEAM Integrating Indicator is as safe and is as effective when used to monitor the claimed steam sterilization cycles and is substantially equivalent to the predicate device.